Label: ANTIMICROBIAL CLEANSING GEL- benzethonium chloride lotion

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated April 29, 2021

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  • DRUG FACTS

    Antimicrobial

  • Active Ingredients

    Benzethonium Chloride (0.2%)

  • Purpose

    Antimicrobial

  • Uses

    B-KLEER™ is a unique, non-drying cleanser. •Designed for all skin types and pH balanced. •Excellent for postoperative care. •May be used as a topical antimicrobial to help protect against skin infection.

  • Warnings

    For external use only.
    Do not use in eyes.
    Ask a doctor before use if you have deep wounds or puncture wounds.
    Stop use and ask a doctor if irritation develops.

    Keep out of reach of children.

  • Directions

    •Wet hands and other areas to be treated. •Place a small amount of gel in your hands and work into lather. •Apply lather to areas to be treated using a gentle, circular motion. •Rinse clean.

  • Other Information

    •Alcohol Free •Moisturizes •Made in USA

  • Inactive Ingredients

    Purified Water, Ammonium Lauryl Sulfate, Lauramidopropyl Betaine, Hydroxypropyl Bis-Hydroxyethyl-dimonium Chloride, Propylene Glycol, Hydroxypropylmethylcellulose, Sodium Chloride, Diazolidinyl Urea, PEG-4 Laurate, Methylparaben, Propylparaben, 3-iodo-2-propynylbutylcarbamate.

  • Questions or Comments

    A-Cute Derm, Inc.

    1810 Cravens Road

    Stafford, TX 77477

    800.922.2883

    M-F 8:30am-5:30pm

    info@a-cutederm.com

    www.a-cutederm.com

  • Principal Display Panel

    antimicrobial antimicrobial

  • INGREDIENTS AND APPEARANCE
    ANTIMICROBIAL CLEANSING GEL 
    benzethonium chloride lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61619-104
    Route of AdministrationCUTANEOUS
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZETHONIUM CHLORIDE (UNII: PH41D05744) (BENZETHONIUM - UNII:1VU15B70BP) BENZETHONIUM CHLORIDE2 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    LAURAMIDOPROPYL BETAINE (UNII: 23D6XVI233)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    AMMONIUM LAURYL SULFATE (UNII: Q7AO2R1M0B)  
    HYDROXYPROPYL BIS-HYDROXYETHYLDIMONIUM CHLORIDE (UNII: 1EO3O1X7HG)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
    PEG-4 LAURATE (UNII: AYF4VM3N1Z)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:61619-104-04118.29 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product02/20/2020
    2NDC:61619-104-32946.35 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product02/20/2020
    3NDC:61619-104-091 in 1 BOX04/29/2021
    3NDC:61619-104-0129.57 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    4NDC:61619-104-08236.59 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product02/20/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E02/20/2020
    Labeler - A-Cute Derm, Incorporated (809845803)
    Establishment
    NameAddressID/FEIBusiness Operations
    Bio-Medical & Pharmaceutical Manufacturing Corporation072186356manufacture(61619-104)
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